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Full-Text Articles in Intellectual Property Law
Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti
Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti
American University Law Review
No abstract provided.
Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier
Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier
Akron Intellectual Property Journal
Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the HatchWaxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and …
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Michigan Telecommunications & Technology Law Review
“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Michigan Telecommunications & Technology Law Review
Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …
Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier
Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier
Michigan Law Review
A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …